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(Sr)Director, Analytical Development & StabilityTorrey Pines Solutions • San Diego, California, United States
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(Sr)Director, Analytical Development & Stability

Torrey Pines Solutions
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States
Jetzt Bewerben

Über

(Sr)Director, Analytical Development & Stability

San Diego, California, United States

ESSENTIAL JOB FUNCTIONS:

  • Responsible for all management aspects of Analytical R&D and Stability from lead optimization into clinical development through validation for commercialization.
  • Will serve as the subject matter expert and lead the analytical research and development/stability study/QC functions with internal and external CRO/CDMOs.
  • Provided direction, leadership, and oversight for all analytical methods development and validation, stability and quality control elements at contract research laboratories and manufacturing organizations.
  • Guide external third parties to perform analytical activities in support of technology transfer, process development, optimization, qualification, and validation related to Drug Substance and Drug Product manufacturing operations.
  • Provide oversight for the transfer of preclinical analytical methods from Research through all clinical phases of development and into QC at commercial manufacturing sites.
  • Author and review CMC sections for all regulatory filings (INDs, IMPDs, NDAs, MAAs).
  • Provide strategic support and technical documentation for answering regulatory questions during submission reviews and throughout clinical development.
  • Responsible for Analytical Development and Stability budget recommendations and management of associated expenses.
  • Provide direction and leadership for Analytical Research & Development and Stability staff.

JOB REQUIREMENTS:

  • BS with 15 + yrs., MS with 12+ yrs., or Ph.D. with 10+ yrs. in analytical sciences or related field.
  • 8+ years of relevant industry experience in analytical development and stability.
  • Demonstrated experience in QC/QA regulations.
  • Familiar with cGMP compliance and ICH guidelines.
  • Experience and management of outsourced projects with contractors.
  • Strong leadership, teamwork, and collaboration skills.
  • Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
  • Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
  • San Diego, California, United States

Sprachkenntnisse

  • English
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